FDA UDI
In Commercial Distribution
🇺🇸 United States
DynaSafety Instant Cold Pack, 4" x 5" (10.2 cm x 12.7 cm)
DI: 00840117333222
·
Model: 4511UB-1
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DynaSafety Instant Cold Pack, 4" x 5" (10.2 cm x 12.7 cm)
- Primary DI
- 00840117333222
- Version / Model
- 4511UB-1
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-29
- Public Version
- 4
- Public Version Date
- 2026-04-22
- Public Version Status
- Update
- Public Device Record Key
- a4d169e4-0b67-4e98-be01-ae4f311e80e2
Device Description
For use whenever instant cold therapy is required
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40555 | Musculoskeletal hot/cold therapy pack, single-use | A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840117333215 | GS1 | Case | 72 | In Commercial Distribution | |
| Primary | 00840117333222 | GS1 |